Product Number: T092002
English Name: Trilaciclib Impurity 2
English Alias: 2'-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7',8'-dihydro-6'H-spiro[cyclohexane-1,9'-pyrazino[1',2':1,5]pyrrolo[2,3-d]pyrimidin]-6'-one
CAS Number: 1374743-01-7
Molecular Formula: C₂₃H₂₈N₈O
Molecular Weight: 432.52
Product Advantages: Trilaciclib Impurity 2 has high purity and good chemical stability. Its structure has been strictly confirmed by multiple precise analytical techniques (such as nuclear magnetic resonance and mass spectrometry), and it remains stable and uniform under different experimental environments and storage conditions. As a reference substance, it can be accurately used for Trilaciclib impurity detection, ensuring accurate, reliable, and highly reproducible detection results, providing a solid basis for pharmaceutical quality research and quality control, and facilitating quality monitoring in drug research, development, and production processes.
Application Fields:
Quality Control: As an impurity reference standard, it is used to establish and validate the detection methods for impurities in Trilaciclib bulk drugs and formulations, ensuring that the sensitivity and specificity of the detection methods meet pharmaceutical quality standard requirements and effectively guaranteeing drug quality.
Process Optimization: During the production of Trilaciclib, by monitoring the content of this impurity and analyzing the stages and causes of its generation, it helps to optimize the synthesis process, reduce impurity formation, and improve product quality and production efficiency.
Stability Studies: In drug stability tests, it analyzes the changes of this impurity under different storage conditions (such as temperature, humidity, light), providing key data support for determining the shelf life and storage conditions of drugs, and ensuring the quality stability of drugs during storage and transportation.
Background Description: Trilaciclib is an innovative drug used to protect bone marrow from chemotherapy damage and plays an important role in cancer treatment. In its research, development, production, and quality control processes, impurity research is a crucial aspect to ensure drug safety and effectiveness. The presence of impurities may affect the drug's efficacy and even pose potential risks. As a related impurity of Trilaciclib, in-depth research on Trilaciclib Impurity 2 helps to comprehensively evaluate the quality of Trilaciclib drugs, improve the drug quality evaluation system, and ensure the safety and effectiveness of clinical medication.
Research Status: Currently, research on Trilaciclib Impurity 2 continues to progress. In terms of detection technology, advanced detection methods such as Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry are constantly being explored to achieve precise detection of trace impurities. In the study of impurity generation mechanisms, the formation causes and influencing factors are deeply analyzed by simulating drug synthesis reactions and storage environments, providing a theoretical basis for optimizing the production process and controlling impurities from the source. In addition, research on the impact of this impurity on the efficacy and safety of Trilaciclib is also gradually being carried out, aiming to further clarify its role in drug quality evaluation and provide more comprehensive evidence for rational clinical medication.
China
